Status:
RECRUITING
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Lead Sponsor:
University Hospital, Lille
Conditions:
Liver Diseases
Acute on Chronic Hepatic Failure
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suff...
Eligibility Criteria
Inclusion
- group A: patients with acute alcoholic hepatitis
- Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (\> 60 g per day for men and\> 40 g per day for women)
- Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- Bilirubin\> 50 mg / l
- Absence of autoimmune liver disease (ANA \<1/80, AML \<1/80, LKM1 neg, AAM neg)
- Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
- Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)
- Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)/ Inflammatory infiltrate with polymorphonuclear neutrophils
- group B1: patients with alcoholic cirrhosis
- Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)
- group B2: patients free from chronic liver disease
- Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)
Exclusion
- For groups A and B1:
- Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
- for group B2:
- Alcoholic liver disease
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03773887
Start Date
September 1 2015
End Date
September 1 2027
Last Update
January 7 2021
Active Locations (1)
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1
Hôpital Claude Huriez, CHRU
Lille, France